Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-02 @ 5:32 AM
Study NCT ID:
NCT02847169
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '925 621-3761', 'title': 'Senior Manager Global Medical Scientific Affairs', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Filcon IV1 Toric Lens', 'description': 'Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.\n\nfilcon IV1 toric lens: toric contact lens', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ocufilcon D Toric Lens', 'description': 'Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.\n\nocufilcon D toric lens: toric contact lens', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Fit Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lens (Baseline)', 'description': 'Habitual data was assessed at baseline.'}, {'id': 'OG001', 'title': 'Filcon IV1 Toric Lens (Baseline)', 'description': 'Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.\n\nfilcon IV1: toric contact lens'}, {'id': 'OG002', 'title': 'Ocufilcon D Toric Lens (Baseline)', 'description': 'Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.\n\nocufilcon D: toric contact lens'}, {'id': 'OG003', 'title': 'Filcon IV1 Toric Lens (1 Week)', 'description': 'Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.\n\nfilcon IV1: toric contact lens'}, {'id': 'OG004', 'title': 'Ocufilcon D Toric Lens (1 Week)', 'description': 'Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.\n\nocufilcon D: toric contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '3.7', 'spread': '0.5', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': "Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Optimal Centration', 'description': 'Lens centration'}, {'id': 'OG001', 'title': 'Decentered Slightly', 'description': 'Lens centration'}, {'id': 'OG002', 'title': 'Substantially Decentered', 'description': 'Lens centration'}], 'classes': [{'title': 'Habitual toric lens', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - filcon IV1 toric', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - ocufilcon D toric', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1 week - filcon IV1 toric', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1 week - ocufilcon D toric', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-blink Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Lens (Baseline)', 'description': 'Habitual lens assessed at baseline.'}, {'id': 'OG001', 'title': 'Filcon IV1 Toric Lens (Baseline)', 'description': 'Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.\n\nfilcon IV1: toric contact lens'}, {'id': 'OG002', 'title': 'Ocufilcon D Toric Lens (Baseline)', 'description': 'Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.\n\nocufilcon D: toric contact lens'}, {'id': 'OG003', 'title': 'Filcon IV1 Toric Lens (1 Week)', 'description': 'Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.\n\nfilcon IV1: toric contact lens'}, {'id': 'OG004', 'title': 'Ocufilcon D Toric Lens (1 Week)', 'description': 'Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.\n\nocufilcon D: toric contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '1.97', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '0.3', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '0.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Toric Lens', 'description': 'Habitual data was assessed at baseline.'}, {'id': 'OG001', 'title': 'Filcon IV1 Toric Lens (Baseline)', 'description': 'Data collected at baseline for filcon IV1 toric lens.'}, {'id': 'OG002', 'title': 'Ocufilcon D Toric Lens (Baseline)', 'description': 'Data collected at baseline for ocufilcon D toric lens.'}, {'id': 'OG003', 'title': 'Filcon IV1 Toric Lens (1 Week)', 'description': 'Data collected at 1 week for filcon IV1 toric lens.'}, {'id': 'OG004', 'title': 'Ocufilcon D Toric Lens (1 Week)', 'description': 'Data collected at 1 week for ocufilcon D toric lens.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '3.7', 'spread': '0.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filcon IV1 Toric Lens', 'description': 'Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.\n\nfilcon IV1: toric contact lens'}, {'id': 'OG001', 'title': 'Ocufilcon D Toric Lens', 'description': 'Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.\n\nocufilcon D: toric contact lens'}], 'classes': [{'title': 'Habitual toric lens - Yes', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Habitual toric lens - No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Yes', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 week - Yes', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': '1 week - No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': 'Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Orientation in Primary Position of Gaze', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Toric Lens', 'description': 'Habitual data was gathered at baseline.'}, {'id': 'OG001', 'title': 'Filcon IV1 Toric Lens (Baseline)', 'description': 'Data collected at baseline for filcon IV1 toric lens.'}, {'id': 'OG002', 'title': 'Ocufilcon D Toric Lens (Baseline)', 'description': 'Data collected at baseline for ocufilcon D toric lens.'}, {'id': 'OG003', 'title': 'Filcon IV1 Toric Lens (1 Week)', 'description': 'Data collected at 1 week for filcon IV1 toric lens.'}, {'id': 'OG004', 'title': 'Ocufilcon D Toric Lens (1 Week)', 'description': 'Data collected at 1 week for ocufilcon D toric lens.'}], 'classes': [{'title': '0 degrees', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}]}, {'title': '<=5 degrees', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': '<=10 degrees', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 week', 'description': "Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rotational Recovery in Degrees After 60 Seconds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Habitual Toric Lens', 'description': 'Habitual data was gathered at baseline.'}, {'id': 'OG001', 'title': 'Filcon IV1 Toric Lens (Baseline)', 'description': 'Data collected at baseline for filcon IV1 toric lens.'}, {'id': 'OG002', 'title': 'Ocufilcon D Toric Lens (Baseline)', 'description': 'Data collected at baseline for ocufilcon D toric lens.'}, {'id': 'OG003', 'title': 'Filcon IV1 Toric Lens (1 Week)', 'description': 'Data collected at 1 week for filcon IV1 toric lens.'}, {'id': 'OG004', 'title': 'Ocufilcon D Toric Lens (1 Week)', 'description': 'Data collected at 1 week for ocufilcon D toric lens.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '4.7', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '4.1', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '8.5', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Filcon IV1 Toric Lens, Then Ocufilcon D Toric Lens', 'description': 'Participants are randomized to wear filcon IV1 toric lens, then ocufilcon D toric lens pair for 1 week each during the cross over study.\n\nfilcon IV1: toric contact lens\n\nocufilcon D: toric contact lens'}, {'id': 'FG001', 'title': 'Ocufilcon D Toric Lens, Then Filcon IV1 Toric Lens', 'description': 'Participants are randomized to wear ocufilcon D toric lens, then filcon IV1 lens pair for 1 week each during the cross over study.\n\nfilcon IV1: toric contact lens\n\nocufilcon D: toric contact lens'}], 'periods': [{'title': 'First Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Participants', 'description': 'Participants are randomized to wear filcon IV1 or ocufilcon D toric lens pair for 1 week during the cross over study.\n\nfilcon IV1: toric contact lens\n\nocufilcon D: toric contact lens'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There was 1 protocol deviation. Therefore, of the 30 subjects who completed the study, data from one subject is not included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2016-07-25', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-28', 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Fit Acceptance', 'timeFrame': 'Baseline and 1 week', 'description': "Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect"}, {'measure': 'Lens Centration', 'timeFrame': 'Baseline and 1 week', 'description': 'Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).'}, {'measure': 'Post-blink Movement', 'timeFrame': 'Baseline and 1 week', 'description': 'Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.'}, {'measure': 'Overall Stability', 'timeFrame': 'Baseline and 1 week', 'description': 'Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.'}, {'measure': 'Corneal Coverage', 'timeFrame': 'Baseline and 1 week', 'description': 'Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)'}, {'measure': 'Lens Orientation in Primary Position of Gaze', 'timeFrame': 'Baseline and 1 week', 'description': "Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead."}, {'measure': 'Rotational Recovery in Degrees After 60 Seconds', 'timeFrame': 'Baseline and 1 week', 'description': 'Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.', 'detailedDescription': 'This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A person is eligible for inclusion in the study if he/she:\n\n * Is between 18 and 40 years of age (inclusive)\n * Has had a self-reported visual exam in the last two years\n * Is an adapted soft toric contact lens wearer\n * Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)\n * Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes.\n * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.\n * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.\n * Has clear corneas and no active ocular disease\n * Has read, understood and signed the information consent letter.\n * Patient contact lens refraction should fit within the available parameters of the study lenses.\n * Is willing to comply with the wear schedule (at least 5 days per week, \\> 8 hours/day assuming there are no contraindications for doing so).\n * Is willing to comply with the visit schedule\n\nExclusion Criteria:\n\n* A person will be excluded from the study if he/she:\n\n * Has a CL prescription outside the range of the available parameters of the study lenses.\n * Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye.\n * Has a history of not achieving comfortable CL wear (5 days per week; \\> 8 hours/day)\n * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.\n * Presence of clinically significant (grade 2-4) anterior segment abnormalities\n * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10\n * Slit lamp findings that would contraindicate contact lens wear such as:\n\n * Pathological dry eye or associated findings\n * Pterygium, pinguecula, or corneal scars within the visual axis\n * Neovascularization \\> 0.75 mm in from of the limbus\n * Giant papillary conjunctivitis (GCP) worse than grade 1\n * Anterior uveitis or iritis (past or present)\n * Seborrheic eczema, Seborrheic conjunctivitis\n * History of corneal ulcers or fungal infections\n * Poor personal hygiene\n * Has a known history of corneal hypoesthesia (reduced corneal sensitivity)\n * Has aphakia, keratoconus or a highly irregular cornea.\n * Has Presbyopia or has dependence on spectacles for near work over the contact lenses.\n * Has undergone corneal refractive surgery.\n * Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT02847169', 'briefTitle': 'Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear', 'orgStudyIdInfo': {'id': 'EX-MKTG-66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'filcon IV1 toric lens', 'description': 'Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.', 'interventionNames': ['Device: filcon IV1 toric lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ocufilcon D toric lens', 'description': 'Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.', 'interventionNames': ['Device: ocufilcon D toric lens']}], 'interventions': [{'name': 'filcon IV1 toric lens', 'type': 'DEVICE', 'description': 'toric contact lens', 'armGroupLabels': ['filcon IV1 toric lens']}, {'name': 'ocufilcon D toric lens', 'type': 'DEVICE', 'description': 'toric contact lens', 'armGroupLabels': ['ocufilcon D toric lens']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Optometry Clinic, National Autonomous University', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Velázquez Guerrero, MSc., FIACLE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Optometry, National Autonomous University (UNAM)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}